REF CH3762 35" — Class II medical device recall Z-1589-2021
Ongoing recall by ICU Medical, Inc., reported 2021-05-19, distributed nationwide. Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers m
| Recall number | Z-1589-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-05-13 |
| Reported by FDA | 2021-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, ES, FR, GB, IT, ZA |
| Reason classes | packaging |
| Lot numbers | 5135759 |
| Model numbers | CH3762 |
Product
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Reason for recall
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1589-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.